Earlier this month, on April 3, PI: Alan Hoffer and Coordinator: Val Cwiklinski at Case Western Reserve University Hospital enrolled the last MISTIE-ICES subject, therefore closing the trial to enrollments! The MISTIE-ICES Trial opened in mid-2008 and has since enrolled 20 subjects across five centers: Barrow Neurological Institute, Case Western Reserve University Hospital, University of California, Los Angeles, University of California, San Diego and the University of Pittsburgh Medical Center.

The MISTIE-ICES Trial is the 3rdtier in Stage I of the MISTIE Trial. The purpose of the MISTIE-ICES Trial is to determine the safety of using either endoscopic surgery (ICES) or a combination of minimally invasive surgery and clot lysis with rt-PA (MISTIE) to remove intracerebral hemorrhage. The ICES arm is led by Drs. Paul Vespa and Neil Martin at the University of California, Los Angeles and Dr. Dan Hanley at Johns Hopkins University.

Dr. Paul Camarata, a neurosurgeon and investigator for the MISTIE trial, was interviewed today about the successful treatment of a patient at the University of Kansas Medical Center. MIS stands for minimally-invasive surgery and is the technique used to place a catheter into the patient's intracerebral hematoma. (ICH, also called intracerebral hemorrhage, is a type of stroke caused by bleeding in the brain). A drug called tissue plasminogen activator (tPA) is then administered into this catheter for 1 to 3 days to breakup the blood clot (by enhancing a natural process called thrombolysis) so it can be drained out of the catheter.

Dr. Daniel F. Hanley presented the results of the MISTIE Phase II trial today at the International Stroke Conference (ISC) in New Orleans. A copy of the abstract, presentation slides and the video are available in this article (click CONTINUE READING for the full article). Also, be sure to see Gayane Yenokyan's recent presentation to the CLEAR III investigators and coordinators on the preliminary outcomes data.

MISTIE Phase II Results: Safety, Efficacy and Surgical Performance

Background: We report the primary clinical outcome results (180 day mRS) for the “Minimally Invasive Surgery plus t-PA for Intracerebral Hemorrhage Evacuation” (MISTIE) trial, a NINDS-funded, two-stage, study of safety, efficacy, and surgical performance that continued to completion after a planned interim analysis showed a strong indication of safety, and efficacy.

After a tremendous effort over several months by all of the staff at the Johns Hopkins BIOS (Brain Injury Outcomes) coordinating center as well as the coordinators and investigators at over 35 investigational sites, we are happy to announce that a grant application has been submitted to the National Institute of Neurological Disorders and Stroke (NINDS, part of the National Institute of Health or NIH) requesting funding for the next phase in the MISTIE clinical development program.